MAUDE Adverse Event Report: CAREFUSION SD TEXIUM NEEDLE-FREE SYRINGE, 5 ML; SYRINGE, PISTON

Model Number	MY8005
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/07/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported by a bd associate that while searching for information on texium, a (b)(6) video was seen wherein the user was demonstrating use of needle-free syringe with bonded texium closed male luer.In the video, it was depicted that sterile water was aspirated from a vial using a needle attached to the product.The needle was then removed.A leak was observed as the user was pushing the fluid into to the needleless connector of a primary tubing while texium male luer is partially connected.There was no patient involvement.
Event or Problem Description
It was reported by a bd associate that while searching for information on texium, a youtube video was seen wherein the user was demonstrating use of needle-free syringe with bonded texium closed male luer.In the video, it was depicted that sterile water was aspirated from a vial using a needle attached to the product.The needle was then removed.A leak was observed as the user was pushing the fluid into to the needleless connector of a primary tubing while texium male luer is partially connected and not fully engaged into smartsite.Bd customer advocacy reached out to the youtube video content creator.The customer reported that he was informed the issue was due to improper use of the product.There was no patient involvement and no one was harmed.
Additional Manufacturer Narrative
Device code added.
Event or Problem Description
It was reported by a bd associate that while searching for information on texium, a youtube video was seen wherein the user was demonstrating use of needle-free syringe with bonded texium closed male luer.In the video, it was depicted that sterile water was aspirated from a vial using a needle attached to the product.The needle was then removed.A leak was observed as the user was pushing the fluid into to the needleless connector of a primary tubing while texium male luer is partially connected.There was no patient involvement.
Additional Manufacturer Narrative
The customer complaint of texium closed male luer leak was confirmed by evaluation of the youtube video.The video shows the user holding the syringe at an angle to the smartsite.It is likely that the texium actuator tabs are being partially engaged by the partially connected smartsite thus allowing liquid to flow through the system.The texium and smartsite present a closed system when they are fully connected per dfu and when connected properly without angling the two components when mating.Device history record could not be performed on model my8005 because the lot # for the suspect set was not provided.The root cause of this failure was not identified as no product was returned.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE, 5 ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10138966
• Report Number: 9616066-2020-01838
• Device Sequence Number: 16606451
• Product Code: FPA
• UDI-Device Identifier: 10885403221668
• UDI-Public: 10885403221668
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MY8005
• Device Catalogue Number: MY8005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 09/02/2020; 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRI TUBING, THERAPY DATE (B)(6) 2014; PRI TUBING, THERAPY DATE (B)(6) 2014